FDA.reportPublic FDA data

WELLBUTRIN

Product NDC
0187-0731
11-digit product format
001870731
Labeler code
0187
Product ID
0187-0731_22308f71-fc56-430d-b559-bed47e17a46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bausch Health US LLC
Application
NDA021515
Marketing category
NDA
Marketing start
2003-08-29
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
WELLBUTRIN
Brand name suffix
XL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541, 993545, 993557, 993564

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-0731-07WELLBUTRINXL7 in 1 BOTTLETABLET, EXTENDED RELEASE727
0187-0731-30WELLBUTRINXL30 in 1 BOTTLETABLET, EXTENDED RELEASE3027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0731-07EA - Each0187-0731905ec048-366b-4d0d-ab5e-d65a4f583b8012021-09-07
0187-0731-30EA - Each0187-07319e7c39e9-03e5-4d43-80fd-ed580b6374cc12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
BUPROPIONACTIVE MOIETY01ZG3TPX31WELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2WELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990WELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0731WELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BAUSCH HEALTH US LLC]23Current NDC, Legacy NDC, 2 package rows20240810_a435da9d-f6e8-4ddc-897d-8cd2bf777b21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
993545Wellbutrin XL 150 MG 24HR Extended Release Oral TabletPSNa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
993564Wellbutrin XL 300 MG 24HR Extended Release Oral TabletPSNa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
99354524 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet [Wellbutrin]SBDa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
99356424 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet [Wellbutrin]SBDa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
99354524 HR Wellbutrin 150 MG Extended Release Oral TabletSYa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
99356424 HR Wellbutrin 300 MG Extended Release Oral TabletSYa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
993545Wellbutrin XL 150 MG 24 HR Extended Release Oral TabletSYa435da9d-f6e8-4ddc-897d-8cd2bf777b2127
993564Wellbutrin XL 300 MG 24 HR Extended Release Oral TabletSYa435da9d-f6e8-4ddc-897d-8cd2bf777b2127

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0187-0731-07001870731077 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-0731-07) 2003-08-290000-00-00NoNoCurrent
0187-0731-300018707313030 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-0731-30) 2003-08-290000-00-00NoNoCurrent